Anti-fever botanical composition and uses thereof

ABSTRACT

According to at least one aspect of the present invention, a botanical anti-fever composition is provided. In at least one embodiment, the botanical composition comprises a therapeutically effective amount of admixture of parts or extracts of at least one plant species from each of genus  Baptisia  and genus  Swertia.  In at least one particular embodiment, the botanical composition contains  Baptisia Tinctoria.  In at least another particular embodiment, the botanical composition contains  Swertia Chirata.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a botanical composition useful as apreventative, alleviative, or remedy for treating one or more symptomsassociated with fever.

2. Background Art

Fever is a common symptom of many medical conditions includinginfectious diseases such as influenza, common cold, HIV (humanimmunodeficiency virus), malaria, infectious mononucleosis, orgastroenteritis; various skin inflammations such as boils, pimples,acne, or abscess; immunological diseases such as lupus erythematosus,sarcoidosis, inflammatory bowel disease; tissue destruction involvinghemolysis, surgery, or infarction; and conditions caused by an adversereaction to medications such as antibiotics or sulfa drugs.

Fever, also known as pyrexia, is often described as an increase ininternal body temperature to levels above the body's thermoregulatoryset-point. Body temperature is regulated in the hypothalamus. Feveroccurs in response to a pyrogen, a triggering substance. A pyrogen maybe endogenous or exogenous to the body. The bacterial substancelipopolysaccharide (LPS) is an example of an exogenous pyrogen andcertain cytokines produced by phagocytic cells are exemplary endogenouspyrogens.

People with fever experience fatigue, arthralgia, myalgia, anorexia, ordelirium. Fever may further cause tachycardia, tachypnea, or an increasein metabolic rate. In situations where the underlying etiology for thefever symptom is inflammatory and or infectious, a fever left untreatedmay be fatal for patients who are weak and febrile.

Additionally, many synthetic drugs such as antibiotics are useful intreating bacterial infections associated with the underlying diseases;however, synthetic drugs often have side effects. By way of example,repetitive and prolonged use of antibiotics are known to induceantibiotics resistance in humans. Also, the use of antibiotics isseverely restricted in pregnant patients.

As such, it is desirable to provide a natural remedy, with less sideeffects or use restrictions, for controlling fever symptoms and/ortreating the underlying conditions associated with fever.

SUMMARY

According to at least one aspect of the present invention, a botanicalanti-fever composition is provided. In at least one embodiment, thebotanical composition comprises a therapeutically effective amount ofadmixture of parts or extracts of at least one plant species from eachof genus Baptisia and genus Swertia. In at least one particularembodiment, the botanical composition contains Baptisia Tinctoria. In atleast another particular embodiment, the botanical composition containsSwertia Chirata.

In at least one embodiment, the botanical composition further comprisesparts or extracts from at least one plant species of a genus selectedfrom the group consisting of genus Azadirachta, genus Eucalyptus, genusAtropa, and any combination thereof. In one particular embodiment, thebotanical composition contains Azadirachta Indica. In another particularembodiment, the botanical composition contains Eucalyptus Globulus. Inyet another particular embodiment, the botanical composition containsAtropa Belladonna.

According to another aspect of the present invention, a method forremedying one or more symptoms associated with fever in a subject isprovided. In at least one embodiment, the method comprises administeringto the subject a therapeutically effective amount of admixturecontaining parts or extracts of at least one plant species from each ofgenus Baptisia and genus Swertia.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

Reference will now be made in detail to presently preferredcompositions, embodiments and methods of the present invention, whichconstitute the best modes of practicing the invention presently known tothe inventors. The Figures are not necessarily to scale. However, it isto be understood that the disclosed embodiments are merely exemplary ofthe invention that may be embodied in various and alternative forms.Therefore, specific details disclosed herein are not to be interpretedas limiting, but merely as a representative basis for any aspect of theinvention and/or as a representative basis for teaching one skilled inthe art to variously employ the present invention.

Except in the examples, or where otherwise expressly indicated, allnumerical quantities in this description indicating amounts of materialor conditions of reaction and/or use are to be understood as modified bythe word “about” in describing the broadest scope of the invention.

It is also to be understood that this invention is not limited to thespecific embodiments and methods described below, as specific componentsand/or conditions may, of course, vary. Furthermore, the terminologyused herein is used only for the purpose of describing particularembodiments of the present invention and is not intended to be limitingin any way.

It must also be noted that, as used in the specification and theappended claims, the singular form “a,” “an,” and “the” comprise pluralreferents unless the context clearly indicates otherwise. For example,reference to a component in the singular is intended to comprise aplurality of components.

Throughout this application, where publications are referenced, thedisclosures of these publications in their entireties are herebyincorporated by reference into this application to more fully describethe state of the art to which this invention pertains.

As used herein, “tincture” refers to an alcoholic extract oralcohol/water extract of a material, in particular, a herb, plant ortree component. The tincture used herein is typically the mothertincture of a component prepared according to the procedures of theHomœopathic Pharmacopœia of the United States (“HPUS”). Procedures forforming the mother tincture are also found in German HomoeopathicPharmacopoeia (“GHP”), 5 edition (Nov. 3, 2003), Medpharm, ISBN-10:3887630955, ISBN-13: 978-3887630959. This procedure from GHP is herebyincorporated by reference. When prepared according these procedures, acomponent is subject to the extracting solvent for an extended period oftime. This results in tinctures with reproducible amounts ofingredients.

Ingredients of the botanical composition may be described by the DecimalScale or the Centesimal Scale. The Decimal Scale is based on theprinciple that first potency (i.e., dilution) should contain 1/10th partof the original drug and each succeeding potency should contain 1/10thof the previous potency. In a variation, this scale is based on themother tincture. The decimal potency is denoted by a suffix includingthe letter ‘X’ to the number indicating the potency. Therefore, thefirst potency is 1X, the second potency is 2X and so on. The CentesimalScale is based on the principle that first potency (i.e., dilution)should contain 1/100th part of the original drug and each succeedingpotency should contain 1/100th of the previous potency. The Centesimalscale is denoted by simply affixing the numerical after the name of thedrug like Hamamelis 200, Millifolium 30, Nux. Vom. 200, etc. In avariation, this scale is also based on the mother tincture. These twosystems for potency are also described in German HomoeopathicPharmacopoeia (“GHP”), 5 edition (Nov. 3, 2003), Medpharm, ISBN-10:3887630955, ISBN-13: 978-3887630959. These descriptions from GHP arehereby incorporated by reference.

As used herein and unless otherwise noted, the term a “therapeuticallyeffective amount” refers to a dose of the botanical composition, whenadministered to a subject, that is able to cause a measurable change infever reduction and amelioration of other fever-related symptoms. Theexact value of a therapeutically effective amount varies based upon thesensitivity and size of each subject, and is readily determinable by oneof skill in the art using conventional procedures for the routineadministration of effective dose.

As used herein and unless otherwise mentioned, the term “efficaciousmaterial” refers to plant matter that is able to elicit a beneficialresponse when administered to a subject. For example, administration ofthe efficacious material to a mammal causes a physiological responsethat results in a lowering of body temperature. The effacacious materialis optionally suspendable and or soluble in an extraction fluid orsolution described herein such that the resulting extracts are able toelicit a similar beneficial response.

As used herein and unless otherwise noted, the term “extract” refers toa substance or composition obtained from one or more plant parts,regardless of whether the substance or composition is found external tothe plant parts (i.e., an exudate). Chemical and/or physical action, aswould be understood in the art, may be required to obtain the substanceor composition from the plant parts. The extract may take the form of asolid, a liquid, or a gas. When the extract is in the liquid form, theextract is also referred to as a tincture.

Synthetic products presently used for the treatment of fever symptomshave many side effects and certain application limitations. The herbalkingdom offers few remedies for fever control. In natural therapy,certain herbal preparations are given mainly to boost the body's immunesystem. However, the use of these known herbal preparations has met withlimited use since these preparations seldom give appreciable feverrelief and or treatment for underlying disease conditions.

The present invention, in at least one embodiment, provides an improvedcomposition having anti-fever properties, which not only provides reliefparticularly in acute febrile conditions but also helps in correctingthe underlying pyrexia disorders. In at least one embodiment, thepresent invention provides an improved botantical composition havinganti-fever properties which controls related symptoms such as bodysoreness, body pain, headache, nausea, cough, excessive sweat, andvomiting.

According to at least one aspect of the present invention, an anti-feverbotanical composition is provided. In at least one embodiment, theanti-fever botanical composition comprises a therapeutically effectiveamount of an admixture containing parts of or extracts of at least oneplant species from each of genus Baptisia and genus Swertia.

The species of the plant genus Swertia illustratively includes Swertiaangustifolia, Swertia bimaculata, Swertia chinensis, Swertia chirayita,Swertia dilatata, Swertia hookeri, Swertia japonica, Swertiamulticaulis, Swertia perennis, Swertia purpurascens, Swertia radiata,and Swertia tongluensis.

The species of the plant genus Baptisia illustratively includes Baptisiaalba, Baptisia albescens, Baptisia arachnifera, Baptisia australis,Baptisia bicolor, Baptisia bracteata, Baptisia bushii, Baptisiacalycosa, Baptisia cinerea, Baptisia confusa, Baptisia cuneata, Baptisiadeamii, Baptisia elliptica, Baptisia fragilis, Baptisia fulva, Baptisiagibbesii, Baptisia hirsuta, Baptisia hugeri, Baptisia intercalate,Baptisia intermedia, Baptisia lactea, Baptisia aevicaulis, Baptisialanceolata, Baptisia lecontei, Baptisia leucantha, Baptisia leucophaea,Baptisia macilenta, Baptisia megacarpa, Baptisia minor, Baptisianuculifera, Baptisia nuttalliana, Baptisia oxyphylla, Baptisia pendula,Baptisia perfoliata, Baptisia pinetorum, Baptisia psammophila, Baptisiariparia, Baptisia saligna, Baptisia simplicifolia, Baptisiasphaerocarpa, Baptisia stricta, Baptisia sulphurea, Baptisia texana,Baptisia tinctoria, Baptisia vespertina, Baptisia viridis, Baptisiaintermedia, and Baptisia variicolor.

In at least another embodiment, at least one species of Swertiacontained within the anti-fever botanical composition is SwertiaChirata. Swertia Chirata is indigenous to temperate Himalayas ataltitudes above 4000 feet from Kashmir, Nepal, and Bhutan. SwertiaChirata is sometimes found in other parts of India. Swertia Chirata isalso known as Chirayata, Kirata-tikta, Kiryat-charayatah, Bhunimba,Bhuchiretta, Charayatah, Chiretta, Chiraita, Indian Gentian,Jwaran-thakah, Kirata, kiraita, Kiriath, Kiriyattu, Kiryat-charayatah,Mahatita, Nila-vemu, Nila-vembu, or Qasabuz-Zarirah. Swertia Chirata hasbeen reported to be bitter tonic, stomachic, febrifuge, anthelmintic,laxative, antidiarrhoeic and antiperiodic. Swertia Chirata contains twobitter components: ophelic acid, an amorphous bitter principle, andchiratin, a yellow bitter glucoside.

In one refinement, the parts or extracts of a member of the genusSwertia (e.g. Swertia Chirata) are present in an amount of 0.0002 weight% to 0.5 weight % of the total weight of the botanical composition. Inanother refinement, the parts or extracts of a member of the genusSwertia are present in an amount of 0.0008 weight % to 0.06 weight % ofthe total weight of the botanical composition. The weight percentagesare provided herein with the understanding that the balance is providedas a suitable liquid such as water. In another refinement, the parts orextracts of a member of the genus Swertia are present in an amount of0.001 weight % to 0.02 weight % of the total weight of the botanicalcomposition. In yet another refinement, the member of the genus Swertiais provided as a first potency 1X composition in an amount from about0.1 to about 5% of the total weight of the botanical composition. Instill another refinement, the member of the genus Swertia is provided asa first potency 1X composition in an amount from about 0.5 to about 2%of the total weight of the botanical composition. In yet anotherrefinement, the member of the genus Swertia is provided as a firstpotency 1X composition in an amount from about 4 to about 12 parts byweight relative to the other components.

In at least one embodiment, at least one species of Baptisia containedwithin the anti-fever botanical composition is Baptisia Tinctoria. Alsoknown as Wild Indigo or Indigoweed, Baptisia Tinctoria is generallyanti-microbial and anti-catarrhal. Baptisia Tinctoria has been used totreat localized infections and catarrh in the ear, nose and throat.Baptisia Tinctoria has also been used in the treatment for laryngitis,tonsillitis, pharyngitis and catarrhal infections of the nose and sinus.Systemically, Baptisia Tinctoria may be helpful in the treatment ofenlarged and inflamed lymph glands (lymphadenitis). Baptisia Tinctoriacontains isoflavones, genistein, biochanin A, flavonoids, and alkaloidssuch as cytisine Coumarins Polysaccharides.

In at least one particular embodiment, the parts or extracts of a memberof the genus Baptisia (e.g, Baptisia Tinctoria) are present in an amountof 0.0002 weight % to 0.5 weight % of the total weight of the botanicalcomposition. In another refinement, the parts or extracts of a member ofthe genus Baptisia are present in an amount of 0.0008 weight % to 0.06weight % of the total weight of the botanical composition. In anotherrefinement, the parts or extracts of a member of the genus Baptisia arepresent in an amount of 0.001 weight % to 0.02 weight % of the totalweight of the botanical composition. In yet another refinement, themember of the genus Baptisia is provided as a first potency 1Xcomposition in an amount from about 0.1 to about 5% of the total weightof the botanical composition. In still another refinement, the member ofthe genus Baptisia is provided as a first potency 1X composition in anamount from about 0.5 to about 2% of the total weight of the botanicalcomposition. In yet another refinement, the member of the genus Baptisiaprovided as a first potency 1X composition in an amount from about 2 toabout 10 parts by weight relative to the other components.

In at least one embodiment, the botanical composition further includesparts or extracts of at least one species of plant genus Eucalyptus. Ina refinement, the extract is provided as a tincture, and in particular,a tincture in about 60% alcohol/water (v/v). (v/v means volume/volume).Prior to forming the botanical composition of the invention, thetincture is optionally diluted with a suitable solvent (e.g., alcohol,water/alcohol). Exemplary species of the genus Eucalyptus is listed athttp://enwikipedia.org/wiki/List_of_Eucalyptus_species, the entirecontent of which is incorporated herein by reference. Eucalyptus is adiverse genus of trees and a few shrubs.

Eucalyptus matures into single-stemmed forest trees, single-stemmedwoodland trees, or multi-stemmed Mallees. The Eucalyptus trees vary insize ranging from 10 meters to 60 meters in height. Eucalyptus have verydistinctive flowers and fruit (capsule). The flowers have numerousfluffy stamens which may be white, cream, yellow, pink or red. Theappearance of Eucalyptus bark varies with the age of the plant, themanner of bark shed, the length of the bark fibers, or the degree offurrowing. Mature eucalypts put on an annual layer of bark, whichcontributes to the increasing diameter of the stems. By way of example,stringybark is characterized as having long-fibers and can be pulled offin long pieces; ironbark is hard, rough and deeply furrowed, and oftenhas a dark red or even black color; tessellated has a bark that isbroken up into many distinct flakes; box type has short fibers; andribbon type has the bark coming off in long thin pieces but stillloosely attached in some places. Eucalyptus is a tall, evergreen treenative to Australia and Tasmania. Among its various species, the bluegum is the one commonly grown in the US. The trunk of the blue gum,which grows to 300 feet high or more, is covered with peeling paperybark. The leaves on the young plant, up to 5 years old, are opposite,sessile, soft, oblong, pointed, and a hoary blue color.

Most Eucalyptus species are known to be antiseptic, anti-microbial,anti-spasmodic, and febrifuge. Most Eucalyptus medications are made fromthe greenish-yellow oil obtained from the mature leaves. The oil, orlozenges and cough drops made from it are useful for lung diseases,colds, and sore throat. The oil can also be used as a vapor bath forasthma and other respiratory ailments, and as an antiseptic bathadditive. Its expectorant properties are useful for bronchitis. The oilis also said to be useful for pyorrhea and for burns and to preventinfection. An essential oil extracted from Eucalyptus leaves containscompounds that are natural disinfectants. Eucalyptus flowers produce agreat abundance of nectar which is a food for insects, birds, and bats.Eucalyptus genus has many other uses which have made them economicallyimportant. The Karri and the Yellow box varieties are best known forproviding desirable characteristics for use as ornament, timber,firewood and pulpwood. Fast growth also makes eucalypts suitable aswindbreaks. Eucalypts draw a tremendous amount of water from the soilthrough the process of transpiration.

In at least another embodiment, the at least one species of theEucalyptus contained within the botanical composition is EucalyptusGlobulus. Useful constituents of Eucalyptus Globulus include1,8-cineole, terpineole, a-pinene, p-cymene, ledol, aromadendrene,viridoflorol; aldehydes, ketones, alcohols, polyphenolic acids; caffeic,ferulic, gallic, protocatechuic, eucalyptin, hyperoside, and rutin.

In at least one particular embodiment, the parts or extracts of a memberof the genus Eucalyptus (e.g., Eucalyptus Globulus) are present in anamount of 0.0002 weight % to 0.5 weight % of the total weight of thebotanical composition. In another refinement, the parts or extracts of amember of the genus Eucalyptus are present in an amount of 0.0008 weight% to 0.06 weight % of the total weight of the botanical composition. Inanother refinement, the parts or extracts of a member of the genusEucalyptus are present in an amount of 0.001 weight % to 0.02 weight %of the total weight of the botanical composition. In yet anotherrefinement, the member of the genus Eucalyptus is provided as a firstpotency 1X composition in an amount from about 0.1 to about 5% of thetotal weight of the botanical composition. In still another refinement,the member of the genus Eucalyptus is provided as a first potency 1Xcomposition in an amount from about 0.5 to about 2% of the total weightof the botanical composition. In yet another refinement, the member ofthe genus Eucalyptus provided as a first potency 1X composition in anamount from about 2 to about 10 parts by weight relative to the othercomponents.

In at least one embodiment, the botanical composition further comprisesparts or extracts of at least one species of plant genus Azadirachta.Numerous species have been described in the genus but only two arecurrently recognized, Azadirachta excelsa (Jack Jacobs), and theeconomically important Neem tree, Azadirachta indica (A. Juss).

In at least another embodiment, at least one species of the Azadirachtacontained within the botanical composition is Azadirachta Indica. In arefinement, the extract is provided as a tincture, and in particular, atincture in about 60% alcohol/water (v/v). (v/v means volume/volume).Prior to forming the botanical composition of the invention, thetincture is optionally diluted with a suitable solvent (e.g., alcohol,water/alcohol). Azadirachta Indica is found in the Western Himalayas ofIndia, and in Iran. It is cultivated in other parts of India and thetropical regions of the world such as Indonesia, Australia, and WestAfrica. Azadirachta Indica is considered to be a very valuable herb inAyurvedic medicine and for a variety of folk applications. AzadirachtaIndica is also known as Neem, Nimba, Nimb, Indian Lilac, Bead Tree, HolyTree, Margosa Tree, Nim, Persian Lilac, Pride of China, Ravipriya, andVeppu. The root and bark of Azadirachta Indica are antiperiodic,astringent, and tonic. The bark of Azadirachta Indica is astringent,antiperiodic, antiviral, bitter, tonic, and vermifuge. The leaves ofAzadirachta Indica are antiviral and discutient (an agent serves todisperse morbid matters). The flowers of Azadirachta Indica arestimulant, stomachic, and tonic. The fruit of Azadirachta Indica isanthelmintic, purgative, and emollient. The juice of Azadirachta Indicais anthelmintic. The oil extracted from the nuts of Azadirachta Indicais antiseptic and insecticidal. Azadirachta Indica has been used as atreatment for inflammatory and febrile diseases.

In at least one particular embodiment, the parts or extracts of a memberof the genus Azadirachta (e.g., Azadirachta Indica) are present in anamount of 0.0002 weight % to 0.5 weight % of the total weight of thebotanical composition. In another refinement, the parts or extracts of amember of the genus Azadirachta are present in an amount of 0.0008weight % to 0.06 weight % of the total weight of the botanicalcomposition. In another refinement, the parts or extracts of a member ofthe genus Azadirachta are present in an amount of 0.001 weight % to 0.02weight % of the total weight of the botanical composition. In yetanother refinement, the member of the genus Azadirachta is provided as afirst potency 1X composition in an amount from about 0.1 to about 5% ofthe total weight of the botanical composition. In still anotherrefinement, the member of the genus Azadirachta is provided as a firstpotency 1X composition in an amount from about 0.5 to about 2% of thetotal weight of the botanical composition. In yet another refinement,the member of the genus Azadirachta provided as a first potency 1Xcomposition in an amount from about 4 to about 12 parts by weightrelative to the other components.

In at least one embodiment, the botanical composition further comprisesparts or extracts of Atropa Belladonna. In a refinement, the extract isprovided as a tincture, and in particular, a tincture in about 60%alcohol/water (v/v). (v/v means volume/volume). Prior to forming thebotanical composition of the invention, the tincture is optionallydiluted with a suitable solvent (e.g., alcohol, water/alcohol). AtropaBelladonna is a perennial herbaceous plant with leaves and berries knownto be toxic and hallucinogenic if overdosed. Atropa Belladonna flowersare solitary, bell-shaped, and dull brown to dark purple in color.Atropa Belladonna fruit is a sweet-tasting, black, shiny berry about thesize of a cherry. Atropa Belladonna is a perennial branching herbgrowing to 5 meter tall, with 18 centimeter long ovate leaves. AtropaBelladonna is not a very hardy perennial and is sensitive to beingtransplanted. Germination requires several weeks in warm, moist,absolutely sterile soil, usually far from normal garden conditions.Atropa Belladonna is also known as Belladonna, deadly nightshade, Blackcherry, and poison black cherry

Atropa Belladonna is an important source of atropine, which is aneffective treatment for the effects of poisoning by cholinesteraseinhibitors such as Parathion and Malathion. Atropine also reverses theeffects of poisoning by nerve agents designed for chemical warfare.Atropa Belladonna extracts can also be found in some over-the-countercold and flu medicines (in small amounts) due to itspseudoephedrine-like properties for clearing up nasal and other passageswhere mucus forms. Donnatal, or the generic Belladonna, is a FDAapproved prescription pharmaceutical that contains natural belladonnaalkaloids combined with Phenobarbital to provide peripheralanticholinergic/antispasmodic action and mild sedation. Donnatalcontains belladonna alkaloids including atropine, hyoscyamine, andscopolamine. Belladonna alkaloids produce many effects in the body,including reduced muscle spasms in the digestive or urinary tract, anreduced fluid secretions from certain glands or organs. Donnatal isindicated and FDA approved as “possibly effective” for the treatment ofIBS (irritable bowel syndrome), acute enterocolitis and as adjunctivetherapy in the treatment of duodenal ulcer.

In at least one particular embodiment, the parts or extracts of a memberof the genus Atropa (e.g., Atropa Belladonna) are present in an amountof 0.0000002 weight % to 0.005 weight % of the total weight of thebotanical composition. In another refinement, the parts or extracts of amember of the genus Atropa are present in an amount of 0.0000008 weight% to 0.0006 weight % of the total weight of the botanical composition.In another refinement, the parts or extracts of a member of the genusAtropa are present in an amount of 0.000001 weight % to 0.0002 weight %of the total weight of the botanical composition. In yet anotherrefinement, the member of the genus Atropa is provided as a thirdpotency 3X composition in an amount from about 0.1 to about 5% of thetotal weight of the botanical composition. In still another refinement,the member of the genus Atropa is provided as a third potency 3Xcomposition in an amount from about 0.5 to about 2% of the total weightof the botanical composition. In yet another refinement, the member ofthe genus Atropa provided as a third potency 3X composition in an amountfrom about 2 to about 8 parts by weight relative to the othercomponents.

As set forth above, it should be appreciated that typically the activeingredients are provided in a carrier such as water. Therefore, thiscarrier will make up the balance. The ingredients may also be providedas a concentrate with the appropriate amounts being the part by weightset forth above (or by rescaling the weight percentages).

The efficacious materials of the anti-fever botanical composition may bederived from one or more selected plant parts of each of the genusSwertia, Baptisia, Azadirachta, Eucalyptus, or Atropa. The selectedplant parts illustratively include barks, stems, leaves, roots, flowers,seeds, nuts, fruits, or any combinations thereof.

The selected plant parts may be directly used as the anti-fevercomposition or may be processed into a form illustratively includingpowder, tablet, capsule, liquid, gel, and food.

The selected plant parts may be processed to form extracts. The extractsmay be processed individually for each plant species or the selectedplant parts of multiple species may be processed together provided thatprocess conditions are suitable for maintaining the effacaciousmaterials contained within the plant parts. One skilled in the artshould be able to decide the extraction conditions suitable forprocessing various plant genus and various plant species thereof bytuning parameters including dryness of starting plant material,extraction temperature, solvent polarity, and solvent acidity.

Extracts of various selected plant parts may be prepared usingconventional methods. One exemplary extraction method is summarizedbelow. In summary form, the method includes: (1) drying the selectedplant parts and milling the dried plant parts to a fine powder; (2)mixing the plant powder to an extraction solvent; (3) removing the plantremnants by centrifugation and collecting the solvent supernatant; (4)removing the remaining solvent and water in the supernatant by rotaryevaporation and drying. One of ordinary skill in the art would realizethat the method may be modified appropriately, e.g., for the transitionfrom a small-, or laboratory-, scale to a commercial-scale method. Thedrying process may not be needed for extraction purposes. Fresh plantmaterial may be directly subjected to solvent extraction without thedrying step. Dried plant parts do offer an advantage in terms oftransport and storage of the crop; however, the activity of the extractfrom air-dried plants may be lower than the activity of freeze-driedextracts due to possible increase in breakdown of components in theair-dried counterparts.

The selected plant parts may be washed and cleaned and subject to afreeze-drying process. The freeze-drying process helps to reduce watercontent within the plant parts such that further processing of the plantparts may be facilitated. An exemplary freeze-drying process is shown inU.S. Pat. No. 6,210,738, the content of which in its entirety isincorporated herein with reference. In general, during the freeze-dryingprocess, water does not exist as a liquid but rather as ice or vapor andsublimates directly from ice to vapor. As temperatures are increased ata controlled rate, the water in the selected plant parts sublimates.Once properly freeze-dried, the selected plant parts may be furtherprocessed alone or in combination with other plant parts in producingthe botanical composition. Alternatively, the washed plant parts may bespray dried or heat dried at a temperature in the range of 50 to 70degrees Celsius with or without vacuum.

The extraction solvent may be a mildly polar fluid. The “mildly polar”fluid means a fluid that is slightly to moderately polar, as would beunderstood in the art. Mildly polar as used herein means moderatelyirregular distribution of electrons that is characterized by a weak toaverage degree of hydrophilicity. A mildly polar fluid includes allstraight chain and branched primary alcohols and chemical derivativesthereof, provided that the additional chemical groups do not destroy thepolarity of the fluid or increase the polarity of the fluid to the levelof water, which is expressly excluded from the definition of a mildlypolar fluid. Preferred mildly polar fluids are liquids, such as thelower molecular weight, straight chain, primary alcohols (e.g.,ethanol). Water is not a mildly polar fluid, but is a highly polaraqueous fluid. However, a mixture of water and a mildly polar fluid(e.g., ethanol) is itself a mildly polar fluid. An example of the latterfluid is 60% ethanol. A variety of mildly polar fluids, such asalcohols, may be used to extract efficacious materials from the selectedplant parts, including methanol, ethanol, and isopropanol. When alcoholis used, the resulting product is an ethanolic extract.

In at least one embodiment, the anti-fever botanical composition furtherincludes one or more general health promoting ingredients. The generalhealth promoting ingredients may include, for example and not by way oflimitation, agnus castus (Vitex agnus-castus), agrimony (Agrimoniaeupatoria), anise (Pimpinella anisum), arjuna (Terminalia arjuna),arnica (Arnica montana), asafoetida (Ferula assa-foetida), astragalus(Astragalus membranaceus), avens (Geum urbanum), bay laurel (Laurusnobilis), Beleric myrobalan (Terminalia belerica), betony (Stachysofficinalis), bilberry (Vaccinium myritillus), bistort (Polygonumbistorta), black cohosh (Cimicifuga racemosa), blackcurrant (Ribesnigrum), black haw (Viburnum prunifolium), bogbean (Menyanthestrifoliata), boldo (Peumus boldus), boneset (Eupatorium perfoliatum),buchu (Barosma betulina), bugleweed (Lycopus virginicus), burdock(Arctium lappa), calendula (Calendula officinalis), calumba (Jateorhizapalmata), cardamom (Eletteria cardamomum), cayenne (Capsicumfrutescens), cerasee (Momordica charantia), cinchona (cinchona),cinnamon (Cinnamomum verum), clove (Eugenia caryophyllata), codonopsis(Codonopsis pilosula), coltsfoot (Tussilago farfara), comfrey (Symphytumofficinale), common plantain (Plantago major), cornsilk (Zea mays),cowslip (Primula veris), crampbark (Viburnum opulus), damiana (Turneradiffusa), dandelion (Taraxacum officinale), devil's claw (Harpagophytumprocumbens), echinacea (Echinacea spp.), eggplant (Solanum melongena),elder (Sambucus nigra), elecampane (Inula helenium), ephedra (Ephedrasinica), evodia (Evodia rutaecarpa), evening primrose (Oenotherabiennis), eyebright (euphrasia spp.), fennel (Foeniculum vulgare),fumitory (Fumaria officinalis), galangal (Alpinia officinarum), garlic(Allium sativum), gentian (Gentiana lutea), ginger (Zingiberofficinale), ginkgo (Ginkgo biloba), goat's rue (Galega officinalis),goldenrod (Solidago vigaurea), hanbane (Hyoscyamus niger), hops (Humuluslupulus), horsemint (Monarda punctata), Indian gooseberry (Emblicaofficinalis), jamaica dogwood (Piscidia erythrina), java tea(Orthosiphon aristata), jujube (Ziziphus jujuba), kantakari (Solanumxanthocarpum), lavender (Lavandula officinalis), lapacho (Tabebuiaspp.), lemon (Citrus limon), lemon balm (Melissa officinalis), licorice(Glycyrrhiza glabra), linden (tilia), lobelia (Lobelia inflata), lycium(Lycium chinense), manioc (Manihot esculenta), meadowsweet (Filipendulaulmaria), milk thistle (Carduus marianus), Muira puama (Liriosma ovata),mullein (Verbascum thapsus), myrrh (Commiphora molmol), nettle (Uriticadioica), oats (Avena sativa), passionflower (Passiflora incarnata),patchouli (Pogostemon cablin), picrorrhiza (Picrorrhiza kurroa), pricklyash (Zanthoxylum americanum), purslane (Protulaca oleracea), rehmannia(Rehmannia glutinosa), rosemary (Rosmarinus officinalis), sarsaparilla(smilax spp.), schisandra (Schisandra chinensis), skullcap (Scutellarialateriflora), slippery elm (Ulmus rubra), soapwort (Saponariaofficinalis), spiny restharrow (Ononis spinosa), squaw vine (Mitchellarepens), sweet basil (Ocimum basilicum), tea tree (Melaleucaalternifolia), tree lungwort (Lobaria pulmonaria), turmeric (Curcumalonga), thyme (Thymus vulgaris), vervain (Verbena officinalis), whitewillow (Salix alba), winter cherry (Physalis alkekengi), withania(Withania somnifera), wormwood (Artemisia absinthium), yarrow (Achilleamillefolium), yellow dock (Rumex crispus) as well as vitamins, mineralsand amino acids.

As explained earlier the botanical composition may be in the form ofcapsules, tablets, powder, syrups and liquids for the purpose ofadministration. In at least one embodiment, the anti-fever botanicalcomposition further includes a pharmaceutically or physiologicallyacceptable formulation agent selected for suitability with the mode ofadministration. Acceptable formulation materials preferably are nontoxicto recipients at the dosages and concentrations employed. Suitableformulation agents are known to those skilled in the art of botanicaland homeopathic compositions. Examples of such compositions include, butare not limited to, talc, sugar mannitol, lactose, pectin, dextrin,gelatin, starch, magnesium stearate, magnesium carbonate, sodiumsaccharine, cellulose, magnesium carbonate, sodiumcarboxymethylcellulose, a low melting wax, cocoa methylcellulose,tragacanth, butter, and the like. Naturally occurring forms of thesematerials are most desirable. In one refinement, the botanicalcomposition includes an agent in an amount of about 5 weight % to about80 weight %.

The effectiveness of the anti-fever botanical composition is determinedby one skilled in the art depending upon, for example, the intendedroute of administration, delivery format, and desired dosage. See forexample, Remington's Pharmaceutical Sciences. Such compositions mayinfluence the physical state, stability, rate of in vivo release, andrate of in vivo clearance of the plant extracts, such as the mildlypolar extracts of plant parts.

In at least another aspect of the present invention, a method forreducing one or more fever related symptoms and or for controllingunderlying disease conditions is provided. The fever related symptomsillustratively include elevated body temperatures, cough, body chill,body ache, headache, nausea, vomit, and excessive sweat. The underlyingdisease conditions illustratively include Q fever, rheumatic fever,dengue fever, dengue hemorrhagic fever, typhoid fever, and otherinfectious or inflammatory conditions.

Q fever is caused by infection with Coxiella burnetii. The organism isfound in cattle, sheep, goats or other domestic mammals. The infectionresults from inhalation of contaminated particles in the air, or fromcontact with the vaginal mucus, milk, feces, urine or semen of infectedanimals. The most common manifestation is flu-like symptoms with abruptonset of fever, malaise, profuse perspiration, severe headache, musclepain, joint pain, dry cough, chills, and gastrointestinal symptoms suchas nausea, vomiting, and diarrhea. The fever lasts approximately 7 to 14days. During the course, the disease may progress to atypical pneumonia,which can result in a life threatening acute respiratory distresssyndrome. The chronic form of the Q fever is similar to the inflammationof the inner lining of the heart (endocarditis), which can occur aftermonths or decades following the infection. It is usually deadly ifuntreated. Treatment of the Q fever with antibiotics may be severelydiscounted in pregnant patients or who are otherwise resistant to theantibiotics.

Rhematic fever is an inflammatory disease which may develop after aGroup A streptococcal infection. Rheumatic fever is common worldwide andresponsible for many cases of damaged heart valves. In the Westerncountries, it became fairly rare since the 1960s, probably due towidespread use of antibiotics to treat streptococcus infections. Whileit is far less common in the United States since the beginning of the20th century, there have been a few outbreaks since the 1980s. Althoughthe disease seldom occurs, it is serious and has a mortality of 2-5%.Rheumatic fever primarily affects children between ages 6 and 15 yearsand occurs approximately 20 days after strep throat or scarlet fever.The rate of development of rheumatic fever in individuals with untreatedstrep infection is estimated to be 3%. Persons who have suffered a caseof rheumatic fever have a tendency to develop flare-ups with repeatedstrep infections. Heart complications may be long-term and severe,particularly if valves are involved.

Dengue fever and dengue hemorrhagic fever (DHF) are acute febrilediseases, found in the tropics and Africa, with a geographical spreadsimilar to malaria. Unlike malaria which is often eradicated in majorcities, dengue is mainly found in urban areas of developed tropicalnations, including Singapore, Taiwan, Indonesia, and Brazil. Dengue istransmitted to humans by the Aedes aegypti mosquito. This infectiousdisease is manifested by a sudden onset of fever, with severe headache,muscle and joint pain and rashes. The dengue rash is characteristicallybright red petechiae and usually appears first on the lower limbs andthe chest; in some patients, it spreads to cover most of the body. Theremay also be gastritis with some combination of associated abdominalpain, nausea, vomiting or diarrhea. The classic dengue fever lasts aboutsix to seven days, with a smaller peak of fever at the trailing end ofthe disease (the so-called “biphasic pattern”). Clinically, the plateletcount will drop until the patient's temperature is normal.

Typhoid fever, also known as enteric fever or bilious fever, is adisease caused by the bacterium Salmonella enterica serovar Typhi. Thedisease is transmitted by the fecal-oral route. The bacterium is aGram-negative short bacillus that is motile due to its peritrichousflagella. Typhoid fever is characterized by a sustained fever as high as40 degrees Celsius or 104 degrees Fahrenheit, profuse sweating,gastroenteritis, and diarrhea. Untreated typhoid fever may developthrough the course of bradycardia, abdominal pain, intestinalhemorrhage, and eventually typhoid state. Typhoid fever in most cases isnot fatal. Antibiotics, such as ampicillin, chloramphenicol, andciprofloxacin, have been commonly used to treat typhoid fever. Whenuntreated, typhoid fever may persist for weeks or months. Death occursin between 10 to 30 percent of the untreated cases.

In another embodiment of the present invention, a method of alleviatingone or more symptoms of fever in a subject (i.e., a human patient) isprovided. The method of this embodiment comprises administering to thesubject a therapeutically effective amount of the botanical compositionsset forth above. The dose of the composition may vary according to theparticular conditions of the patients.

In at least one embodiment, the method includes administering to asubject a therapeutically effective amount of the botanical compositionsset forth above. In one refinement, an amount from about 3.0 to about6.0 ml of the botanical composition is administered to the subject perday. In another refinement, an amount from about 6.0 to about 12 ml ofthe botanical composition is administered to the subject per day. Inanother refinement, an amount from about 9.0 to about 18 ml of thebotanical composition is administered to the subject per day. Thecomposition will be administered to a subject for a sufficient number ofday to alleviate a symptom related to fever. Typically, this time periodis from about 3 days to about 6 months. In another refinement, the timeperiod is from about 5 days to about 3 months. In still anotherrefinement, the time period is from about 7 days to about 1 month.

The threshold for fever that should prompt evaluation is arbitrary anddepends on the patient setting and condition. For example, an otherwisehealthy patient with a single fever to 38.3 degrees Celsius immediatelyafter routine uncomplicated abdominal surgery would rarely requiresignificant evaluation. In contrast, an elderly patient with unexplaineddelirium and temperature to 38.0 degrees Celsius requires a morethorough evaluation. In addition, some patient populations including theelderly are known to have lower temperatures at baseline or theset-point.

The botanical compositions as set forth above may be administeredorally, parentally such as intravenously, by intramuscular injection, byintraperitoneal injection, or transdermally. The exact dose of thebotanical composition required may vary from subject to subject,depending on the age, weight, general condition of the subject, theseverity of disease conditions associated with fever, the mode ofadministration, and the like. An appropriate dose is readily determinedby one of ordinary skills in the art using only routine experimentationgiven the teachings herein.

For oral administration, fine powders or granules may contain diluting,dispersing, and/or surface active agents, and may be presented in wateror in a syrup, in capsules or sachets in the dry state or in anon-aqueous solution or suspension wherein suspending agents may beincluded, in tablets wherein binders and lubricants may be included, orin a suspension. Where desirable or necessary, flavoring, preserving,suspending, thickening, or emulsifying agents may be included. Tabletsand granules may further be coated.

The following examples illustrate the various embodiments of the presentinvention. Those skilled in the art will recognize many variations thatare within the spirit of the present invention and scope of the claims.

1. Preparation—Exemplary Botanical Composition Formulation

Respective tinctures are added in the following formula: 8 drops of thetincture of Swertia Chirata; 6 drops of the tincture of BaptisiaTinctoria; 8 drops of the tincture of Azadirachta Indica; 8 drops of thetincture of Eucalyptus Globulus; and 5 drops of the tincture of AtropaBelladonna. The tincture mixture is brought up to a final volume of 30milliliters with distilled water and comprise a botanical composition.

2. Study Relief of Signs and Symptoms Associated with Fever in PediatricPatients

The prime objective of the study was to establish the safety andefficacy of a botanical composition as described in Example 1, above.Pediatric patients diagnosed with fever fulfilling theinclusion/exclusion criteria were enrolled in the study. A total of 39patients participated in the study and were available for follow-up.These same patients are included in the report.

Methods

The investigational botanical composition was provided in suspensiondosage form for oral administration. Depending upon the patient'smedical condition any of the following schedules were utilized at thediscretion of the investigational monitor: a) 5 drops every 2 hrs (0-1year old), b) 10 drops every 2 hrs (1-2 years old) or c) 15 drops every2 hrs (2-5 years old) in the course of a 24 hour period.

The investigation enrolled approximately 40 pediatric patients up to 5years of age, diagnosed with a fever up to 102 degrees Fahrenheit. Otherthan the fever manifestation, the patients were also required to bepresent within 12 hours of initial onset and free from noticeablesystemic or functional diseases.

The patients were dosed, according to the schedule shown above, for 24hours and follow-up evaluation was performed at least once within 24hours. The response rate was calculated as the number of respondersdivided by the number of patients who qualified for efficacy analysis.Safety was analyzed based on evaluation of adverse event rates and WHOtoxicity grade laboratory and clinical parameters.

Results

The overall response to the investigational botanical product was 83.3%.Approximately 5% showed no change in symptoms and approximately 8%showed an aggravation of their symptoms. The study found the botanicalinvestigational product was effective in reducing fever. In additionpatients showed a reduction in fever related symptoms including:malaise, headache, body ache. A summary of individual symptoms andimprovement are shown below in Table I.

TABLE I Efficacy Results for Individual Symptoms Number of PatientsPercent with Aggra- No Amelio- of Ame- Symptom Symptom vation Changeration lioration a Fever 37 3 2 32 86.5% b Malaise 34 3 2 29 85.3% cHeadache 35 3 3 29 82.9% d Body ache 34 3 4 27 79.4% e Dry cough 33 3 525 75.8% f Sneezing 33 3 2 28 84.8% g Nasal discharge 32 3 2 27 84.4% hNausea & 17 3 2 12 70.6% Vomiting i Weakness 39 3 2 36 92.3% j Further 00 0 0 0 complications Average Percentage 83.3% of Amelioration

The botanical antipyretic treatment is effective in reducing fever inpediatric patients less than 5 years old. The botanical combination isalso active in reducing symptoms associated with fever includingmalaise, headache and body aches. The treatment was especially effectivein reducing general weakness. However, the treatment although effectivewas not found to be as effective against a dry cough or nausea andvomiting. The preliminary overall effectiveness of the botanicalantipyretic treatment was determined in the absence of a placebo group.Additional controlled studies are indicated including older children andadults.

While embodiments of the invention have been illustrated and described,it is not intended that these embodiments illustrate and describe allpossible forms of the invention. Rather, the words used in thespecification are words for description rather than limitation, and itis understood that various changes may be made without departing fromthe spirit and scope of the invention.

1. An anti-fever botanical composition comprising: a therapeuticallyeffective amount of an admixture containing parts of or extracts of atleast one plant species from each of genus Baptisia and genus Swertia.2. The botanical composition of claim 1, wherein at least one species ofBaptisia employed is Baptisia Tinctoria.
 3. The botanical composition ofclaim 2, wherein the parts or extracts of Baptisia Tinctoria are about0.0002 to 0.5 percent by weight.
 4. The botanical composition of claim1, wherein at least one species of Swertia employed is Swertia Chirata.5. The botanical composition of claim 4, wherein the parts or extractsof Swertia Chirata are about 0.0002 to 0.5 percent by weight.
 6. Thebotanical composition of claim 1, wherein the admixture furthercomprising parts or extracts from at least one plant species of a genusselected from the group consisting of genus Azadirachta, genusEucalyptus, genus Atropa, and any combination thereof.
 7. The botanicalcomposition of claim 6, wherein at least one species of Azadirachtaemployed is Azadirachta Indica.
 8. The botanical composition of claim 6,wherein the parts or extracts of Azadirachta Indica are about 0.0002 to0.5 percent by weight of the total weight of the botanical composition.9. The botanical composition of claim 6, wherein at least one species ofEucalyptus employed is Eucalyptus Globulus.
 10. The botanicalcomposition of claim 9, wherein the parts or extracts of EucalyptusGlobulus are about 0.0002 to 0.5 percent by weight of the total weightof the botanical composition.
 11. The botanical composition of claim 6,wherein at least one species of Atropa is Atropa Belladona.
 12. Thebotanical composition of claim 11, wherein the parts or extracts ofAtropa Belladona are about 0.0000002 to 0.05 percent by weight of thetotal weight of the botanical composition.
 13. The botanical compositionof claim 1 further comprising a pharmaceutically acceptable formulationagent.
 14. The botanical composition of claim 1 being formulated into adosage form selected from a group consisting of tablets, capsules,liquids, powders, pills, and confectionary bars.
 15. An anti-feverbotanical composition comprising: a therapeutically effective amount ofan admixture containing parts or extracts of Swertia Chirata in anamount of 0.0002 to 0.5 percent by weight; parts or extracts of BaptisiaTinctoria in an amount 0.0002 to 0.5 percent by weight; and one or morepharmaceutically acceptable formulation agents.
 16. The botanicalcomposition of claim 15 further comprising parts or extracts ofAzadirachta Indica in an amount of 0.0002 to 0.5 percent by weight. 17.The botanical composition of claim 15 further comprising parts orextracts of Eucalyptus Globulus in an amount of 0.0002 to 0.5 percent byweight.
 18. The botanical composition of claim 15 further comprisingparts or extracts of Atropa Belladonna in an amount of 0.0002 to 0.5percent by weight.
 19. A method for reducing fever and amelioratingfever related symptoms in a subject, comprising: administering to thesubject a therapeutically effective amount of admixture containing partsor extracts of at least one plant species from each of genus Baptisiaand genus Swertia.
 20. The method of claim 19 further comprising addingto the admixture parts or extracts from at least one plant species of agenus selected from the group consisting of genus Azadirachta, genusEucalyptus, genus Belladonna, and any combination thereof.